FLEXMORE
- Product NDC
- 54973-3397
- 11-digit product format
- 549733397
- Labeler code
- 54973
- Product ID
- 54973-3397_eb95bb71-9607-1885-e053-2995a90a9eda
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Atropa Belladonna, Bryonia Alba Root, Colchicum Autumnale Bulb, Guaiacum Officinale Resin, Kalmia Latifolia Leaf, Rhododendron Tomentosum Leafy Twig, Ruta Graveolens Flowering Top, Tribasic Calcium Phosphate, Comfrey Root and Toxicodendron Pubescens Leaf
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Hyland's
- Marketing category
- UNAPPROVED HOMEOPATHIC
- Marketing start
- 2019-06-01
- Marketing end
- 0000-00-00
- Substance
- ATROPA BELLADONNA; BRYONIA ALBA ROOT; COLCHICUM AUTUMNALE BULB; COMFREY ROOT; GUAIACUM OFFICINALE RESIN; KALMIA LATIFOLIA LEAF; RHODODENDRON TOMENTOSUM LEAFY TWIG; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF; TRIBASIC CALCIUM PHOSPHATE
- Active strength
- 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 54973-3397 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 54973-3397 | 54973-3397-1 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 54973-3397 | 54973-3397-2 | D | Discontinued by firm | 2026-10-05 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 54973-3397-2 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 54973-3397-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 54973-3397-2 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 54973-3397-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 54973-3397-2 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 54973-3397-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 54973-3397-2 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 54973-3397-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 54973-3397-2 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 54973-3397-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 54973-3397-2 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 54973-3397-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 54973-3397-2 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 54973-3397-1 | 302b2466d912… | e7b80fea0513… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 54973-3397-1 | 54973339701 | 1 BOTTLE, PLASTIC in 1 CARTON (54973-3397-1) > 50 TABLET in 1 BOTTLE, PLASTIC | 2019-06-01 | 0000-00-00 | No | No | Current | |
| 54973-3397-2 | 54973339702 | 4 TABLET in 1 PACKET (54973-3397-2) | 4 tablet | 2019-06-01 | 0000-00-00 | Yes | No | Current |